510(k) · Cleared
ClearedScanX Intraoral View
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Duerr Dental AG · MUH System, X-Ray, Extraoral Source, Digital
Cleared on May 1, 2017 as substantially equivalent to K160788 (Ray Co., Ltd., 2016) after a 52-day review. Its family tree reaches back 4 generations to 1994. 5 later devices descend from it.
- Decided
- May 1, 2017
- Review
- 52 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K934949 (1994). 5 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK934949 DigoraOrion Corporation Soredex · 1994
- 3 generations backK041050 Digora Optime (or Digora Ontime)Soredex Palodex Group OY · 2004 · Recalled
- 2 generations backK131442 Firecr Dentalimaging System3Disc Americas · 2013
- 1 generation backK160788 RIOScan (RPS500)Ray Co., Ltd. · 2016
- This deviceK170733 ScanX Intraoral ViewDuerr Dental AG · 2017
- Descendant · cites it directly · 1 of its ownK212080 Imaging Plate Scanner, i-ScanGuilin Woodpecker Medical Instrument Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK202633 ScanX EdgeDürr Dental SE · 2020
- Descendant · 2 generations on · 0 of its ownK231660 Digital image scanner of dentalJiangsu Dynamic Medical Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK230095 ScanX Swift 2.0, ScanX Swift View 2.0Durr Dental SE · 2023
- Descendant · cites it directly · 0 of its ownK191623 ScanX Touch/ScanX Duo TouchAir Techniques, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K212080Imaging Plate Scanner, i-ScanGuilin Woodpecker Medical Instrument Co., Ltd. · 2021 · cites it directly1descendant
- K202633ScanX EdgeDürr Dental SE · 2020 · cites it directly1descendant
- K231660Digital image scanner of dentalJiangsu Dynamic Medical Technology Co., Ltd. · 2023 · 2 generations on0descendants
- K230095ScanX Swift 2.0, ScanX Swift View 2.0Durr Dental SE · 2023 · 2 generations on0descendants
- K191623ScanX Touch/ScanX Duo TouchAir Techniques, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K934949 | Digora | Orion Corporation Soredex | 1994 | — |
| −3 | K041050 | Digora Optime (or Digora Ontime) | Soredex Palodex Group OY | 2004 | 4 |
| −2 | K131442 | Firecr Dentalimaging System | 3Disc Americas | 2013 | — |
| −1 | K160788 | RIOScan (RPS500) | Ray Co., Ltd. | 2016 | — |
| 0 (this device) | K170733 | ScanX Intraoral View | Duerr Dental AG | 2017 | — |
| +1 | K212080 | Imaging Plate Scanner, i-Scan | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021 | — |
| +1 | K202633 | ScanX Edge | Dürr Dental SE | 2020 | — |
| +2 | K231660 | Digital image scanner of dental | Jiangsu Dynamic Medical Technology Co., Ltd. | 2023 | — |
| +2 | K230095 | ScanX Swift 2.0, ScanX Swift View 2.0 | Durr Dental SE | 2023 | — |
| +1 | K191623 | ScanX Touch/ScanX Duo Touch | Air Techniques, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160788 | RIOScan (RPS500)Summary page 6…to the RIOScan RPS500 Dental Radiography System manufactured by RAY Co., Ltd whose dental units are in commercial distribution and are FDA cleared under 510K # K160788. ScanX Intraoral View and the RIOScan RPS500 capture, digitize, and process intraoral x-ray images that are stored in i… | 2016 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K212080 (Guilin Woodpecker Medical Instrument Co., Ltd., 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The ScanX Intraoral View is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170733 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170733: ScanX Intraoral View.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170733
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026